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Drug

Nilotinib

Approved · EMA
Emerging researchLate-stage developmentRising momentum

Also known as Danziten, Tasigna, Nilotinibum.

RxNorm662281ChEMBLCHEMBL255863ATCL01EA03UNIIF41401512X
3
Research papers
14
Active clinical trials
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment

Clinical trial2026-07-06Results expected Q3 2030 · ClinicalTrials.gov

Phase II Study of Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis From Colorectal, Appendiceal, Small Bowel, Gastric, Cholangiocarcinoma, Breast, Ovarian, or Other Gynecologic Primary Cancer

Clinical trial2026-06-25Results posted · ClinicalTrials.gov

Phase II Study of Adding the Anti-PD-1 Pembrolizumab to Tyrosine Kinase Inhibitors in Patients With Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease

Clinical trial2026-06-18Results expected Q3 2028 · ClinicalTrials.gov

A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of Low Doses of Nilotinib Treatment on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease

Clinical trial2026-06-12Results posted · ClinicalTrials.gov

A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of Nilotinib Treatment on Safety, Tolerability, Pharmacokinetics and Biomarkers in Dementia With Lewy Bodies (DLB)

Clinical trial2026-06-12Results posted · ClinicalTrials.gov

A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

Clinical trial2026-06-08Results posted · ClinicalTrials.gov

Recall (Class III): NILOTINIB

Regulatory2026-02-18FDA

Approval: Nilotinib Accord (EMA)

Regulatory2024-08-22EMA

European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia.

Research2020-03-03Leukemia

Phase II Study of Nilotinib in Melanoma Harboring KIT Alterations Following Progression to Prior KIT Inhibition.

Research2015-02-18Clinical cancer research : an official journal of the American Association for Cancer Research

Nilotinib reverses loss of dopamine neurons and improves motor behavior via autophagic degradation of α-synuclein in Parkinson's disease models.

Research2013-05-10Human molecular genetics

Approval: Tasigna (EMA)

Regulatory2007-11-19EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Nilotinib
Aliases & brands
DanzitenTasignaNilotinibum
RxNorm CUI
662281
ChEMBL ID
CHEMBL255863
ATC codes
L01EA03
UNII
F41401512X
Regulatory jurisdictions
fdaema

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2007-11-19
Latest approval
2024-08-22
Authorities
FDA · EMA
Total events
3
fdaU.S. Food and Drug Administration· 1 event
2026-02-18RecallSafety
Recall (Class III): NILOTINIB
Evidence ↗
emaEuropean Medicines Agency· 2 events
2024-08-22Approval
Approval: Nilotinib Accord (EMA)
Indication: Nilotinib Accord is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in… Show full indication

Nilotinib Accord is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, - adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available, - paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.

Evidence ↗
2007-11-19Approval
Approval: Tasigna (EMA)
Indication: Tasigna is indicated for the treatment of: adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic… Show full indication

Tasigna is indicated for the treatment of: adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, paediatric patients with Philadelphia chromosome positive CML in chronic phase with resistance or intolerance to prior therapy including imatinib. Tasigna is indicated for the treatment of: adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available, paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

125 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
125
registered trials across all phases
LATEST COMPLETION 2026
14
Active studies
7
Recruiting
42
Late-stage (III+)
79
Completed
32
Discontinued
PHASE DISTRIBUTIONn = 125
Early Phase 12Phase 117Phase 1 / 210Phase 254Phase 325Phase 416Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment

RecruitingPH IVNovartis Pharmaceuticalsn=3472030

An Open-label, Multi-center, Single-arm Study to Evaluate the Efficacy of Nilotinib in Adult Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line Treatment

CompletedPH IVNovartis Pharmaceuticalsn=342024

Sustained Treatment-free Remission in BCR-ABL+ Chronic Myeloid Leukemia: a Prospective Study Comparing Nilotinib Versus Imatinib With Switch to Nilotinib in Absence of Optimal Response. SUSTRENIM Study - GIMEMA CLM1415

Unknown statusPH IVGruppo Italiano Malattie EMatologiche dell'Adulton=4502024

An Open Label, Multi-center Nilotinib Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Nilotinib Study and Are Judged by the Investigator to Benefit From Continued Nilotinib Treatment

CompletedPH IVNovartis Pharmaceuticalsn=572023

A Phase IV Single Arm, Multicenter, Open-label Study Assessing Deep Molecular Response in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive CML in Chronic Phase After Two Years of Treatment With Nilotinib 300mg BID

CompletedPH IVNovartis Pharmaceuticalsn=1712021

Recent completions

Trials that read out recently, adding to the completed evidence base.

Molecular Profiling of Advanced Soft-tissue Sarcomas. A Phase III Study

CompletedPH IIIInstitut National de la Santé Et de la Recherche Médicale, Francen=6032026

A Phase II, Single-arm Study of De-escalation and Treatment-free Remission in Patients With Chronic Myeloid Leukemia Treated With Nilotinib in First-line Therapy Followed by a Second Attempt After Nilotinib and Asciminib Combination: DANTE Study

CompletedPH IINovartis Pharmaceuticalsn=1242025

Imatinib Mesylate (Glivec) as Maintenance Therapy After Cytogenetic Response With Nilotinib (AMN107, Tasigna) First Line in Newly Diagnosed Chronic Myelogenous Leukemia

CompletedN/AAmerican University of Beirut Medical Centern=132025

Phase I Study of Nilotinib Given With Radiation For Patients With High Risk Chordoma

CompletedPH IMassachusetts General Hospitaln=232025

A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of Nilotinib Treatment on Safety, Tolerability, Pharmacokinetics and Biomarkers in Dementia With Lewy Bodies (DLB)

CompletedPH IIGeorgetown Universityn=432025

A Phase 2, Multi-center, Open-label, Randomized Study of Oral Asciminib Added to Imatinib Versus Continued Imatinib Versus Switch to Nilotinib in Patients With CML-CP Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response

CompletedPH IINovartis Pharmaceuticalsn=1042025

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20132020
Major research themes1
Autophagy1
Journals, researchers & institutions
Top journals
  • Clinical cancer research : an official journal of the American Association for Cancer Research1
  • Human molecular genetics1
  • Leukemia1
Leading researchers
  • Antonescu CR1
  • Apperley JF1
  • Baccarani M1
  • Bastian BC1
  • Carvajal RD1
  • Cervantes F1
  • Chapman PB1
  • Clark RE1
Leading institutions
free-text, unnormalised
  • Almazov National Research Centre1
  • Amsterdam University Medical Center1
  • Angeles Clinic and Research Institute1
  • Beverly Hills Cancer Center1
  • Centre Hospitalier de Versailles1
  • Centre Hospitalier Universitaire de Poitiers1

Related drugs

3 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Bosutinib

Studied across the same disease area as Nilotinib in the shared literature.

1 shared disease1 shared paper
Dasatinib

Studied across the same disease area as Nilotinib in the shared literature.

1 shared disease1 shared paper
Imatinib Mesylate

Studied across the same disease area as Nilotinib in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.